NUEDEXTA is PROVEN
to reduce PBA EPISODES

PBA (Pseudobulbar Affect) is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury.

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Actual patients with PBA taking NUEDEXTA

Above: Actual patients with PBA taking NUEDEXTA

82% fewer PBA episodes**

Research in a 12-week clinical trial showed that patients who took the recommended dose of NUEDEXTA had drastic reductions in PBA symptoms and episodes.

Average reduction in a 12-week clinical trial*

Week 12 82% fewer episodes
compared to 45% on placebo**

in final 2 Weeks 51% were episode free
compared to 29% on placebo**

Couple hugging

Patients taking NUEDEXTA experienced an average of 3.9 less episodes per day compared with 6.8 episodes per day before taking NUEDEXTA. Patients taking placebo experienced an average of 3.0 less episodes per day compared with 4.5 episodes per day before taking placebo.**

*Researchers conducted a 12-week clinical trial. This trial was randomized and double-blind and enrolled 326 patients. NUEDEXTA is the first and only treatment approved by the FDA to treat PBA.

**Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.

PBA affects almost
2 MILLION

people in the US who have certain neurologic conditions including Stroke, Alzheimer’s Disease and Dementia, ALS (Lou Gehrig’s Disease), Multiple Sclerosis, and Parkinson’s Disease or Traumatic Brain Injury (TBI).†‡

†Work SS, Colamonico JA, Bradley WG, Kaye RE. Pseudobulbar affect: an under-recognized and under-treated neurological disorder. Adv Ther. 2011;28:586–601.

‡This is not a complete list. Other neurologic conditions have also been associated with PBA.

Robert - Patient with TBI and PBA, taking NUEDEXTA

Robert
Patient with TBI and PBA, taking NUEDEXTA

Learn more about PBA

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Steps to get started

Because PBA episodes are unpredictable and can happen at inappropriate times, they can leave you feeling misunderstood and frustrated. You might even feel disconnected from the people who care for you. But PBA is treatable. Follow these steps to prepare yourself to talk to the people close to you and to your doctor about PBA and treatment.

Send Me PBA Conversation Cards

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Talk to the people close to you

Use the PBA conversation cards to learn how to talk to the people close to you about your crying and/or laughing symptoms. Communication is important in order for both them and you to understand how your symptoms are bothering you and affecting your lives.

Talk to your doctor

Start the conversation about PBA with your doctor. Advocating for yourself is important and doctors want to hear from you so they can help. You can also share your PBA Quiz results.

Ask about NUEDEXTA

If your doctor diagnoses you with PBA, ask if NUEDEXTA could be the right treatment for you. Ask about possible side effects of NUEDEXTA.

Caregiver of patient with PBA

Remember, you are your best advocate

When you talk about your PBA episodes, be specific and don’t hold back—the more details you can provide, the easier it will be for your doctor to understand what you are experiencing.

Carol - Patient with Traumatic Brain Injury and PBA, taking NUEDEXTA
Carol
Patient with Traumatic Brain Injury and PBA, taking NUEDEXTA

“My whole PBA journey has given me a lot of life lessons, and really strengthened our family because they went through this with me.” 

See Carol’s Story
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Understand the treatment

Learn how to take NUEDEXTA and what to expect during treatment, and review important safety information.

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INDICATION and IMPORTANT SAFETY INFORMATION for
NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)

INDICATION:

NUEDEXTA is approved for the treatment of Pseudobulbar Affect (PBA).

PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.

NUEDEXTA is only available by prescription.

IMPORTANT SAFETY INFORMATION:

Before you take NUEDEXTA, tell your doctor:

  • If you are taking monoamine oxidase inhibitors (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.
  • If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.
  • About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.
  • If you have had heart disease or have a family history of heart rhythm problems. NUEDEXTA may cause serious side effects, including changes in heart rhythm. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.
  • If you have myasthenia gravis.

IMPORTANT SAFETY INFORMATION: (Continued)

While taking NUEDEXTA, call your doctor right away:

  • If you feel faint or lose consciousness.
  • If you experience lightheadedness, chills, fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
  • If you have unexplained bleeding or bruising. Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.
  • If you feel dizzy, since it may increase your risk of falling.
  • If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.

The most common side effects of NUEDEXTA include: diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

You are encouraged to report side effects of NUEDEXTA® (dextromethorphan HBr and quinidine sulfate). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read FULL PRESCRIBING INFORMATION.